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510(k) K083553

NASO-LARYNGO-PHARYNGOSCOPE by Schoelly Imaging, Inc. — Product Code EOB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 2009
Date Received
December 1, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nasopharyngoscope (Flexible Or Rigid)
Device Class
Class II
Regulation Number
874.4760
Review Panel
EN
Submission Type

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Schoelly Imaging, Inc.

  • K090800 — VS-100 ILLUMINATION AND IMAGING SYSTEM (May 18, 2009)
  • K090601 — FSC 2 (May 11, 2009)
  • K060899 — FLEXILUX II CYSTOSCOPE AND HYSTEROSCOPE (March 2, 2007)
  • K053412 — FLEXISCOPE, MODELS 50MH AND 50 MHC (February 23, 2006)

Other clearances for product code EOB

  • K241731 — Outlook Surgical Versa One System (8900139) (August 11, 2025)
  • K243639 — Portare System (FA-001) (June 5, 2025)
  • K243380 — VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500) (March 3, 2025)
  • K234096 — MonoStereo (September 19, 2024)
  • K232435 — Rhinolaryngoscope system (April 26, 2024)
  • K232015 — ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507. (August 3, 2023)
  • K222587 — PatCom Distal Chip Endoscope (July 28, 2023)
  • K230536 — Single-use Flexible Rhinolaryngoscope; Digital Video Monitor (June 14, 2023)
  • K221660 — RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP (December 28, 2022)
  • K221581 — Single-Use Flexible Rhinolaryngoscope (November 18, 2022)